ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000081314

Ethics application status

Approved

Date submitted

5/01/2017

Date registered

16/01/2017

Date last updated

20/12/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Feasibility of an online mindfulness-based program for patients with melanoma

Scientific title

Feasibility of an online mindfulness-based program for patients with melanoma – Pilot RCT

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1191-3609

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Melanoma

Condition category

Condition code

Cancer

Malignant melanoma

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is a 6-week online mindfulness-based program designed to: (1) help patients understand the potential benefits of using mindfulness in their day to day life; (2) support the establishment of daily meditation practice. Each week of the program explores a different topic, which builds on the topic explored the week before. The program includes three main components: (1) educational component – weekly themes related to the application of mindfulness. Participants are invited to watch at the beginning of each week, a series of videos (the number varies for each week), each 40 seconds to 60 seconds long. The scripts of those videos can be downloaded if participants wish to refer to the information at a later stage; (2) informal practice. Participants are given a weekly mindfulness-based task to practice during their daily activities; and (3) formal meditation practice. Participants are asked to practice meditation twice daily for 5 minutes each time. This time is increased to 10 minutes each practice from week 3 onwards.
Participants will receive an email at the start of each week with a link to a brief questionnaire inquiring about their level of engagement with the program. Following completion of the questionnaire, participants will be directed to a video introducing the theme for the upcoming week. At the end of each video, participants will be reminded to keep up with their daily meditation practice (formal practice), and will be given a specific mindfulness task to practice during their daily activities (informal practice).
To support participants with establishing a meditation routine, emails containing a link to a short, guided meditation audio file will be sent to participants twice daily. These emails will serve as reminders to meditate and will provide easy access to the meditation practice of the week.
The website will have a section addressing common questions about meditation, which participants will be able to consult at any time throughout the course of the program.
The mindfulness program can be accessed at any time via direct login to the Website or via the hyperlink sent to participants in the weekly e-mails.
The software used to run the mindfulness program will allow tracking of participants’ online activity, including login date/times, navigation patterns, page views and duration, and features used (video, audio, and document downloads). A set of three questions will be presented weekly to capture information on any use of other types of meditation unrelated to the intervention, and frequency of practice. Another three questions will estimate the amount of informal practice over the past week, and the specific use of the weekly topic, using a 5-point Likert scale. These questions will be presented to users at the end of each week, prior to the introduction of the next weekly topic.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Intervention code [3]

Lifestyle

Comparator / control treatment

The control group will only receive usual care, and will have access to the intervention at the end of the 6-week period.
Usual care for patients who have completed treatment for stage 2c or 3 melanoma (criteria for study eligibility) consist of quarterly follow-up visits, which comprise physical examination and PET (Positron Emission Tomography) scanning to monitor potential recurrences, new primaries, or metastatic disease.

Control group

Active

Outcomes

Primary outcome [1]

Study feasibility as determined through:
- overall recruitment (ratio of patients completing the baseline questionnaires over those approached for the study), retention across the six weeks and extent of completion of all questionnaire items described under "secondary outcomes" (ratio of participants who complete the post 6-week study period questionnaire over those who have completed the baseline questionnaire) .
- adherence to the program (online monitoring and weekly questionnaire on meditation and mindfulness-based practice - questionnaire specifically designed for the study)
- program content relevance (questionnaire specifically designed for the study)

Timepoint [1]

at study completion

Secondary outcome [1]

Fear of cancer recurrence Inventory (FCRI), a 42-item questionnaire. It is a multidimensional scale intended for use with all cancer patients. The FCRI consist of seven domains: triggers, severity, psychological distress, functional impairment, reassurance, insight and coping strategies. It has shown high internal consistency, and good construct and criterion validity in a group of adults with different cancer types, and in 286 adults with a history of melanoma.

Timepoint [1]

- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)

Secondary outcome [2]

Rumination subscale (RRQ-Rum) is a 12-item questionnaire that will measure “ruminative self-attention,” the tendency to dwell on, rehash, or re-evaluate events or experiences. Items are rated on a 5-point Likert scale from “strongly disagree” (1) to “strongly agree” (5). The scale showed good internal reliability in a sample of newly diagnosied colon cancer patients and mixed cancer patients (Cronbach’s alpha = 0.90 and 0.92, respectively).

Timepoint [2]

- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)

Secondary outcome [3]

Penn State Worry Questionnaire - Abbreviated (PSQW-A) is an 8-item scale that will assess trait worry by capturing the excessiveness, prevalence, and uncontrollability of clinically worry. Items on the PSWQ-A are rated from 1 (not at all) to 5 (very typical) and total scores range from 8 to 40,with higher scores indicating greater worry. The PSWQ-A is a valid and reliable measure for use among older adults and women with cancer with internal consistency of 0.87 and 0.96 respectively.

Timepoint [3]

- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)

Secondary outcome [4]

Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is a 10 item self-report questionnaire measuring trait mindfulness.This scale uses everyday language appropriate for those with little meditation experience, and is designed to capture mindfulness as a general daily experience. The questionnaire comprises four domains of mindfulness (attention, present-focus, awareness, and acceptance/non judgment). Patients are asked to rate on a four-point Likert scale how much they relate to each statement. Possible responses are 1=rarely/not at all; 2=sometimes; 3=often; 4=almost always.
Compared to other measures of mindfulness, the CAMS-R is unique in that it is related to psychological distress, which is highly relevant to the current study population.

Timepoint [4]

- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)

Secondary outcome [5]

Perceived Stress Scale (PSS10) is a self-report questionnaire measuring the global perception of stress. The items were designed to evaluate how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale has internal consistency ranging from 0.75 to 0.86. Consistent with this range, studies measuring perception of stress in people with prostate cancer and breast cancer had Cronbach’s alpha of 0.78 and 0.87 respectively.

Timepoint [5]

- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)

Eligibility

Key inclusion criteria

Eligible patients will meet the following criteria:
- Have a melanoma diagnosis of stage 2c, 3a, 3b, or 3c
- Have completed their last treatment within the past five years
- Aged 18 years or over
- Sufficient understanding of English to consent and participate
- Have access to internet
- Have an email account or willing to create one for the study
- Willing to commit to a 6-week program and to completing brief assessment measures.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients in the following situation will be not be eligible:
- Waiting to start treatment for a melanoma recurrence or another primary
- Currently receiving treatment for a melanoma recurrence or another primary
- Diagnosed with distant metastasis (stage 4)
- Severe cognitive impairment or intellectual disability, as reported in the medical record or determined by the treating clinician or oncology nurse

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation not concealled

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

10/02/2017

Actual

21/02/2017

Date of last participant enrolment

Anticipated

Actual

8/09/2017

Date of last data collection

Anticipated

Actual

13/09/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

Deakin University
221 Burwood Highway
Burwood 3125
Victoria

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University

Address

Deakin University
221 Burwood Highway
Burwood 3125
Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Center Human Research Ethics Committee

Ethics committee address [1]

305 Grattan Street
Melbourne Victoria
3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/09/2016

Approval date [1]

04/01/2017

Ethics approval number [1]

HREC/16/PMCC/139

Summary

Brief summary

This study will explore the feasibility of delivering an online 6-week mindfulness-based intervention (MBI) to patients with increased risk of melanoma recurrence.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have a melanoma diagnosis of stage 2c, 3a, 3b, or 3c, for which you have completed your last treatment within the past five years. You will also require access to the internet.

Study details
Participants in this study will be randomly allocated (by chance) to the 6-week online mindfulness based intervention (MBI) or usual care group. The MBI is designed to: (1) help patients understand the potential benefits of using mindfulness in their day to day life; and (2) support the establishment of daily meditation practice. Each week of the program explores a different topic, which builds on the topic explored the week before. The program includes three main components: (1) educational component – weekly themes related to the application of mindfulness; (2) informal practice; and (3) formal meditation practice. Participants allocated to the usual care group will continue to receive their usual care for the first 6 weeks of the study, after which they will be offered the MBI.

All participants will be asked to complete questionnaires assessing fear of cancer recurrence, worry, rumination, stress and mindfulness before and after the 6-week study period. Intervention adherence, meditation quality and home tasks will also be assessed weekly. If this intervention proves to be feasible, and trends for changes in outcome measures are observed, a larger randomised-controlled study will be planned to assess intervention efficacy and cost-effectiveness.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Trish Livingston

Address

Deakin University
221 Burwood Highway
Burwood 3125
Victoria

Country

Australia

Phone

+61 3 9244 6609

Fax

[email protected]

Contact person for public queries

Name

Mrs Lahiru Russell

Address

Deakin University
221 Burwood Highway
Burwood 3125
Victoria

Country

Australia

Phone

+61423694939

Fax

[email protected]

Contact person for scientific queries

Name

Mrs Lahiru Russell

Address

Deakin University
221 Burwood Highway
Burwood 3125
Victoria

Country

Australia

Phone

+61423694939

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A pilot randomised controlled trial of an online mindfulness-based program for people diagnosed with melanoma.	2019	https://dx.doi.org/10.1007/s00520-018-4574-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically